跳至主要内容
临床试验/NCT04040764
NCT04040764进行中(未招募)不适用

The Tritanium Uncemented Prosthesis Versus the Cemented Triathlon Prosthesis

Royal Devon and Exeter NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
60
试验地点
2
主要终点
Assessment and comparison of Trabecular Bone Score (TBS) between patients undergoing two different types of knee replacement fixation - uncemented Tritanium knee replacement and cemented Triathlon knee replacement.

研究概览

简要总结

The Study aims to investigate whether there is a clinically important difference in peri-articular bone mineral density (BMD) and trabecular bone score (TBS) between patients undergoing two different types of knee replacement fixation - uncemented Tritanium total knee replacement (TKR) and cemented Triathlon TKR.

Before undertaking a full randomised control trial however, it is necessary to establish that the proposed methodology and approach are feasible. Therefore an internal pilot study will be performed first. This registration is for the internal pilot study.

详细描述

There have been many studies published that have shown a reduction in bone density around knee replacements. Exact reasons for this are not fully understood but one theory is that the stresses transmitted to the bone around a new knee replacement do not adequately load the surrounding bone due to the stress shielding effects of the cement. Bone requires itself to be loaded by weight-bearing pressure in order to maintain its density and structural integrity.

A loss of bone density around the knee has potentially significant consequences for patients. The ability of the bone to support the knee replacement may be compromised, potentially leading to subsidence and failure of the joint replacement. Patients are known to be more prone to falls within 1 year of having a TKR in comparison to age matched controls who have not undergone knee replacements. The incidence of falls following knee replacement was shown to be 38% in one study after the first year post-operatively, compared to 24% in non-TKR subjects. A reduction in bone density following TKR also renders patients more prone to aseptic loosening and fracture around the knee replacement with potentially disastrous consequences.

The majority of research seems to demonstrate a loss of BMD around the knee at around 12 months following TKR surgery, with the most significant BMD decrease occurring between the period of 5-12 weeks post-surgery, occurring primarily at the periprosthetic region. Up to 68% of patients have been reported as showing BMD loss after TKR at the distal anterior femur within the first 12 months post-operatively. The possible fracture risk associated with this has been investigated. Women aged ≥ 70 years who have undergone TKR surgery are 1.6 times more likely to have a fracture than younger patients and 2.3 times more likely to suffer a fracture than men.

Bone density is measured by use of Dual X-ray Absorbitometry scans (DEXA). However, DEXA bone density measurement alone provides an incomplete picture of bone strength. DEXA measurement is derived from the bone mineral content (BMC) divided by bone area, but does not account for the distribution of the trabeculae and the structural integrity of the microarchitecture. This has led to the development of a tool called the trabecular bone score (TBS) which is able to differentiate between microarchitectures that exhibit the same density.

Advancement in technology has led to re-designs in uncemented knee replacements. These newer implants are able to withstand torsional stresses that previously would have concerned surgeons who feared implant movement in the early post-operative phase. The development of biologic coatings on to TKR components also means that bony on-growth and thus stability of the knee implant is achieved much more quickly than was previously. Surgeons have become keener to use such uncemented devices and recent research has shown comparable results in terms of patient satisfaction, Oxford Knee Scores and the need for revision surgery between cemented and uncemented devices.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

The following people will be blinded as to which arm of the study the patient is allocated to:

  • The patient
  • The statistician who performs the analysis of the results
  • The radiographer reporting upon the DXA scan results

入排标准

年龄范围
50 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing primary TKR at the RD+E Hospital
  • Patients must have completed a consent form for the study
  • Patients must be prepared to comply with the pre and post-operative investigations, attendance schedule and questionnaire schedule of the study
  • If the knee for surgery is suitable for standard condylar TKR components
  • The diagnosis is of tricompartmental osteoarthritis of the knee
  • Aged 50-70 years at time of surgery

排除标准

  • Refusal to consent to the study
  • If the knee for surgery is not suitable for standard condylar TKR.
  • Pregnancy
  • Prisoners
  • A patient known to have substance abuse or psychological disorders that could interfere with their ability to comply with the assessment schedules
  • Patients unable to read or understand the patient information leaflet and consent form
  • Patients who have a Body Mass Index (BMI) ≥ 38
  • Patient has an active or suspected latent infection in or about the affected knee joint at time of study device implantation
  • Patient has received any orthopaedic surgical intervention to the lower extremities within the past year or is expected to require any orthopaedic surgical intervention to the lower extremities, other than the TKR to be enrolled in this study, within the next year
  • Patient requires bilateral total knee replacements, or has a history of unsuccessful contralateral partial or total knee replacement
  • Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device
  • Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's disease) leading to progressive bone deterioration
  • Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days)
  • Patients currently taking bisphosphonate medication or have taken within the previous 10 years
  • The presence of peri-articular cysts evident on the pre-operative x-ray such as could compromise the stability at the bone implant interface if the uncemented component is used
  • A past history of tibial or femoral osteotomy surgery

结局指标

主要结局

Assessment and comparison of Trabecular Bone Score (TBS) between patients undergoing two different types of knee replacement fixation - uncemented Tritanium knee replacement and cemented Triathlon knee replacement.

时间窗: Our primary outcome is TBS scores at 12 months post total knee replacement

We plan to compareTBS data between patients randomised to the 2 arms of the trial: the uncemented Tritanium and cemented Triathlon total knee replacement. TBS is a texture parameter that evaluates gray-level pixel-by-pixel variations and provides an assessment of fracture risk. TBS is calculated from patients DEXA scan results and is in a numerical format. Baseline TBS scores will be calculated from pre-operative DEXA scans and will be compared to post op scores. Any differences in TBS scores will be compared between participants in the 2 arms of the trial.

次要结局

  • The Forgotten Joint Score (FJS): Patient reported outcome measure (PROM)(Pre-operatively, 6 weeks post op, 6 and 12 months post op.)
  • The Knee Injury and Osteoarthritis Outcome Score (KOOS): Patient reported outcome measure (PROM)(Pre-operatively, 6 weeks post op, 6 and 12 months post op.)
  • EQ5D: Patient reported outcome measure (PROM)(Pre-operatively, 6 weeks post op, 6 and 12 months post op.)
  • Oxford Knee Score: Patient reported outcome measure (PROM)(Pre-operatively, 6 weeks post op, 6 and 12 months post op.)
  • Hospital Anxiety and Depression Scale (HADS): Patient reported outcome measure (PROM)(Pre-operatively, 6 weeks post op, 6 and 12 months post op.)
  • Assessment and comparison of Trabecular Bone Score (TBS) between patients undergoing two different types of knee replacement fixation - Uncemented Tritanium knee replacement and cemented Triathlon knee replacement.(6 weeks and 6 months post-op.)

研究者

发起方
Royal Devon and Exeter NHS Foundation Trust
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验